Clinical evaluation of AusDiagnostics SARS-CoV-2 multiplex tandem PCR assay
Background In the context of the pandemic, the rapid emergency use authorisation of diagnostic assays for SARS-CoV-2 has meant there are few peer-reviewed published studies of clinical performance of commercial assays. Aims To evaluate the clinical performance of AusDiagnostics respiratory multiplex...
- Autores:
- Tipo de recurso:
- Article of journal
- Fecha de publicación:
- 2020
- Institución:
- Universidad de Bogotá Jorge Tadeo Lozano
- Repositorio:
- Expeditio: repositorio UTadeo
- Idioma:
- eng
- OAI Identifier:
- oai:expeditiorepositorio.utadeo.edu.co:20.500.12010/12461
- Acceso en línea:
- https://www.sciencedirect.com/science/article/pii/S1386653220301906?via%3Dihub
http://hdl.handle.net/20.500.12010/12461
https://doi.org/10.1016/j.jcv.2020.104448
- Palabra clave:
- Coronavirus
Síndrome respiratorio agudo grave
COVID-19
SARS-CoV-2
Coronavirus
Diagnosis
MT-PCR
SARS-CoV-2
Diagnosis
- Rights
- License
- Acceso restringido
| Summary: | Background In the context of the pandemic, the rapid emergency use authorisation of diagnostic assays for SARS-CoV-2 has meant there are few peer-reviewed published studies of clinical performance of commercial assays. Aims To evaluate the clinical performance of AusDiagnostics respiratory multiplex tandem PCR assay including SARS-CoV-2. Methods We reviewed the results following implementation of AusDiagnostics respiratory multiplex tandem PCR assay including SARS-CoV-2, and compared with an in-house RT-PCR assay at our State Reference Laboratory. Results Initial validation using AusDiagnostics coronavirus multiplex tandem PCR assay including SARS-CoV-2 demonstrated good concordance with the State Reference Laboratory. After implementing the AusDiagnostics respiratory multiplex tandem PCR assay including SARS-CoV-2, we tested 7839 samples. 127 samples in which SARS-CoV-2 was detected using the AusDiagnostics assay were referred for testing at the State Reference Laboratory, with concordant results in 118/127 (92.9%) of samples. After resolution of discrepancies, 125/127 (98.4%) of AusDiagnostics results were determined to be true positive results. Out of 7839 samples tested for SARS-CoV-2 during this period, only 2 tests (0.02%) were indeterminate results. Conclusion The AusDiagnostics respiratory MT-PCR assay is a reliable assay for detection of SARS-CoV-2. |
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